Every blank field in the eCRF is a missing datum. Therefore, if lab reports do not show Pus Cells, RBCs Cells and Casts, there are two possibilities. Option one: the lab report indicates microscopic alterations only if positive. In this case the Investigator should record the result in […]
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Alerts and Recommendations | DEEP Project
When does the subject take the last dose of the Investigational Medicinal Product (IMP)?
V15 constitutes the final visit on treatment evaluation. During this visit (besides the usual physical exam and blood samples inclusive of pregnancy tests), the treatment drug must be administered in the clinic under supervision of qualified staff and the time of administration recorded accordingly (for the assessment of […]
How to manage the Microscopic Examination in Urinalysis section?
Every blank field in the eCRF is a missing datum. Therefore, if lab reports do not show Pus Cells, RBCs Cells and Casts, there are two possibilities. Option one: the lab report indicates microscopic alterations only if positive. In this case the Investigator should record the result in […]
When does the subject take the last dose of the Investigational Medicinal Product (IMP)?
V15 constitutes the final visit on treatment evaluation. During this visit (besides the usual physical exam and blood samples inclusive of pregnancy tests), the treatment drug must be administered in the clinic under supervision of qualified staff and the time of administration recorded accordingly (for the assessment of […]